FDA 510(k) Application Details - K994429

Device Classification Name Set, Administration, Intravascular

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510(K) Number K994429
Device Name Set, Administration, Intravascular
Applicant VENUSA LTD.
31C BUTTERFIELD TRAIL
EL PASO, TX 79906 US
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Contact ROSS MAGLADRY
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 12/30/1999
Decision Date 03/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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